Transdermal Ketoprofen to Treat Mild to Moderate Osteoarthritis (OA) Pain of the Knee

Randomized, Double-Blind, Parallel, Placebo Controlled 4 Week Proof-of-Concept Study to Evaluate the Safety and Efficacy of Transdermal Ketoprofen When Administered With Controlled Heat in Patients With Mild to Moderate OA Pain of the Knee

The purpose of the study is to evaluate the safety and effectiveness of the investigational ketoprofen patch with a controlled heating patch, compared to placebo (inactive substance) for the treatment of pain caused by osteoarthritis.

Study Overview

• Status: Completed
• Conditions: Pain; Osteoarthritis, Knee
• Intervention / Treatment: Drug: Transdermal Ketoprofen Patch with CHADD; Drug: Placebo transdermal patch

Detailed Description

Proof-of-concept study, multicenter, randomized, double-blind, parallel-group, placebo-controlled study designed to evaluate the safety and efficacy of a transdermal ketoprofen patch with CHADD heat versus a placebo patch with dummy heat in patients with mild to moderate pain associated with osteoarthritis of the knee. After screening, patients discontinue all analgesic medication (except ≤325 mg aspirin daily for cardioprotective purposes). Patients selected a target knee (right or left), and all efficacy evaluations were completed with respect to this target knee. After discontinuing analgesics for at least 48 hours, and when the average pain intensity over the previous 24 hours for the target knee was ≥40 mm using a 100 mm visual analog scale (VAS), patients were randomized in a 1:1 fashion to receive treatment with either the transdermal ketoprofen patch with CHADD heat or the placebo patch with dummy heat. Patients treated the target knee each night for 12 hours (± 1 hour) for 4 weeks. Patients returned to the study site every 7 days (± 1 day) for study evaluations. Throughout the study, patients were allowed to take up to 2000 mg acetaminophen per day as rescue medication; however, rescue medication was not allowed within the 48 hours prior to efficacy evaluations.

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Buena Park, California, United States, 90620
      • Southbay Pharma Research
  • District of Columbia
    • Washington, District of Columbia, United States, 20006
      • The Center for Rheumatology and Bone Research
  • Florida
    • Daytona Beach, Florida, United States, 32114
      • Radiant Research
    • Pembroke Pines, Florida, United States, 33024
      • University Clinical Research
  • New York
    • New York City, New York, United States, 10021
      • Hospital for Special Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient is between forty (40) and seventy-five (75) years of age.
• Patient has clinically diagnosed radiographic evidence of osteoarthritis of the knee within the past year.

Exclusion Criteria:

• Patient has known allergy to nonsteroidal anti-inflammatory drugs (NSAIDs) (including aspirin) or has a suspected hypersensitivity, allergy or other contraindication to any compound present in the study medication.
• Patient has a history of significant gastrointestinal disease or previous gastrointestinal upset following NSAID administration.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transdermal Ketoprofen Patch with CHADD	Drug: Transdermal Ketoprofen Patch with CHADD; 12 hours patch application for 28 days; Other Names: Matrix Transdermal Ketoprofen/CHADD Sytem
Placebo Comparator: Placebo patch and a dummy heating unit	Drug: Placebo transdermal patch; 12 hours application for 28 days; Other Names: Placebo patch with dummy heating unit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in the WOMAC pain subscale score	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants wih adverse events		28 days
Patient Global Satisfaction score	Patient global satisfaction score at Study Visit 5	28 days
Mean change from baseline for average pain over the last 24 hours VAS scores		28 days

Collaborators and Investigators

• Sponsor: ZARS Pharma Inc.
• Investigators: Principal Investigator: David Borenstein, MD, The Center for Rheumatology; Principal Investigator: H F Farmer, MD, Radiant Research Inc.; Principal Investigator: Larry Gilderman, DO, University Clinical Research; Principal Investigator: Soledad Lee, MD, Southbay Pharma Research; Principal Investigator: Joseph A Markenson, MD, Hospital for Special Surgery, New York

Study record dates

Study Major Dates

• Study Start: April 1, 2005
• Primary Completion (Actual): October 1, 2005
• Study Completion (Actual): October 1, 2005

Study Registration Dates

• First Submitted: April 18, 2005
• First Submitted That Met QC Criteria: April 18, 2005
• First Posted (Estimate): April 19, 2005

Study Record Updates

• Last Update Posted (Estimate): June 5, 2012
• Last Update Submitted That Met QC Criteria: May 30, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: Osteoarthritis; Pain; OA; Mild to Moderate Osteoarthritis (OA) Pain of the Knee
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ketoprofen
• Other Study ID Numbers: ZMK-202